End Stage CancerNCT04016038
Psychosocial Approach and Sedation Practices
An observational study of End Stage Cancer, run by Assistance Publique Hopitaux De Marseille at 2 sites in France.
Trial summary
This study aims to explore deeply the representations and emotional impact of MS on caregivers (doctors and nurses) and relatives of cancer patients. It also aims to describe their collaboration modalities, roles and responsibilities during the decision-making process, implementation and "control" of MS. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Cancer
- What is being tested?
- a psycho-social investigation
- How many people
- 110 participants
- Where
- 2 sitesFrance
- Study dates
- 1 Jun 2019to 1 Jul 2022
- How long will I take part?
- 36 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: In the framework of the QualiPaS_OBS study, the observations will be made by a psychologist integrated into each care team during the observations observation period - no professional activity other than observations. The population studied in the QualiPaS_OBS phase corresponds to the members of the health care team practicing within the eight teams of the services participating in the study, as well as secondarily the patients and relatives of the patients concerned by the activity of the team in question. during the observation period.
Who may be able to join
- Men and women
- Anyone from the team during the observation period
- Having accepted the presence of the observer
- Aged over 18
Who cannot join
- Members of the health care team not present during the observation period
- Member of the team refusing the presence of the observer
Trial locations and contacts
2 sites in 1 country.
Patrcik SUDOUR contact
France2 sites, 2 recruiting
- Not yet recruiting
Assistance des Hôpitaux de Marseille
Marseille, 13354
Lionel Dany, 06.63.42.41.04, Lionel.Dany@univ-amu.fr
Patrick Sudour, 04 91 38 29 03, promotion.interne@ap-hm.fr
- Recruiting
Assistance Publique Hopitaux de Marseille
Marseille, 13354
Lionel Dany, PhD, lionel.dany@ap-hm.fr
About this study
Official title: Sedation in Palliative Care Management Context for Cancer Patients
This study aims to explore deeply the representations and emotional impact of MS on caregivers (doctors and nurses) and relatives of cancer patients. It also aims to describe their collaboration modalities, roles and responsibilities during the decision-making process, implementation and "control" of MS. The project is a multi-center psychosocial study (home, hospitals and palliative care unit) that will take the form of a comprehensive qualitative study, both prospective (participant observation) and retrospective (interview), of patients with and without cancer, for which MS has been administered.
Read the detailed description
Scientific Background: Physicians have an ethical obligation to relieve the refractory symptoms of patients with advanced cancer. In some situations, in the face of physical symptoms and psycho-existential distress, usual treatment is not effective and palliative sedation (PS) is one of the only acceptable options. The carers, but also the relatives of the patient, are particularly involved in the process of decision-making, information and management of sedation. Despite the interest of MS practice and its impact on different levels (relational, emotional, professional, ethical), and contrary to the important development of international studies in this field, there is a lack of research in France.
Objectives of the project and a brief description of the methods: This study aims to explore in depth the representations and emotional impact of MS on carers (doctors and nurses) and relatives of cancer patients. It also aims to describe their collaboration modalities, roles and responsibilities during the decision-making process, implementation and "control" of MS. The project is a multi-center psychosocial study (home, hospitals and palliative care unit) that will take the form of a comprehensive qualitative study, both prospective (participant observation) and retrospective (interview), of patients with and without cancer, for which MS has been administered.
Expected Outcomes: The expected results are the production of original knowledge about the practice of MS in different clinical settings (hospital, home), a better understanding of the psychosocial determinants of palliative sedation decision-making, an update of knowledge transferable to develop palliative care programs that integrate the experiential, emotional, and contextual dimensions of palliative sedation, a better understanding of the communication skills needed to cope with this practice, and an awareness of health care teams and advocates. public health on this subject.
- Conditions
- End Stage Cancer
- Being tested
- a psycho-social investigation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
a psycho-social investigationOther
The design of this project is based partly on the UNBIASED international study and is based on an in-depth case study in a prospective and retrospective dimension of deceased cancer patients for whom sedation has been established, and this, during a given period in different care settings: home, care center, hospital and palliative care unit.
| Study group | Role | What they receive |
|---|---|---|
| QualiPas Observational | Prospective qualitative study through a participant observation procedure with 8 care teams practicing within Palliative Care Units, Palliative Care Mobile Team or Territorial Palliative Care Team. Receives: Other: a psycho-social investigation | |
| QualiPas clinical interview | Qualitative study retrospective research interviews with the doctor and another carer involved in the care of the patient, and close relatives of patients who had sedated before their death. The interviews will be based on 50 cases of patients who have been sedated. Receives: Other: a psycho-social investigation | |
| QualiPas Focus | Qualitative study by group focus group interviews with clinical teams participating in the project. Receives: Other: a psycho-social investigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessing the quality of life
Quality of Life Questionnaire
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2019
- Study start1 Jun 2019
- Primary completion1 Jul 2019 (estimated)
- Study completion1 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for End Stage CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 110 participants (estimated)
- Target duration
- 36 Months
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emilie Garrido, Study director, Assistance Publique Hopitaux De Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04016038
- Sponsor's protocol ID
- 2018-64
- Status last verified
- Jul 2019
- First submitted
- 16 Apr 2019
- Last updated
- 11 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Vieille M, Dany L, Coz PL, Avon S, Keraval C, Salas S, Bernard C. Perception, Beliefs, and Attitudes Regarding Sedation Practices among Palliative Care Nurses and Physicians: A Qualitative Study. Palliat Med Rep. 2021 May 24;2(1):160-167. doi: 10.1089/pmr.2021.0022. eCollection 2021.
PubMed 34223516
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sedation in Palliative Care Management Context for Cancer Patients
- ClinicalTrials.gov ID
- NCT04016038
- Acronym / sponsor ID
- 2018-64
- Conditions
- End Stage Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 1 Jul 2019 (estimated)
- Study completion
- 1 Jul 2022 (estimated)
- First posted
- 11 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to explore deeply the representations and emotional impact of MS on caregivers (doctors and nurses) and relatives of cancer patients. It also aims to describe their collaboration modalities, roles and responsibilities during the decision-making process, implementation and "control" of MS. The project is a multi-center psychosocial study (home, hospitals and palliative care unit) that will take the form of a comprehensive qualitative study, both prospective (participant observation) and retrospective (interview), of patients with and without cancer, for which MS has been administered.
Detailed description
Scientific Background: Physicians have an ethical obligation to relieve the refractory symptoms of patients with advanced cancer. In some situations, in the face of physical symptoms and psycho-existential distress, usual treatment is not effective and palliative sedation (PS) is one of the only acceptable options. The carers, but also the relatives of the patient, are particularly involved in the process of decision-making, information and management of sedation. Despite the interest of MS practice and its impact on different levels (relational, emotional, professional, ethical), and contrary to the important development of international studies in this field, there is a lack of research in France.
Objectives of the project and a brief description of the methods: This study aims to explore in depth the representations and emotional impact of MS on carers (doctors and nurses) and relatives of cancer patients. It also aims to describe their collaboration modalities, roles and responsibilities during the decision-making process, implementation and "control" of MS. The project is a multi-center psychosocial study (home, hospitals and palliative care unit) that will take the form of a comprehensive qualitative study, both prospective (participant observation) and retrospective (interview), of patients with and without cancer, for which MS has been administered.
Expected Outcomes: The expected results are the production of original knowledge about the practice of MS in different clinical settings (hospital, home), a better understanding of the psychosocial determinants of palliative sedation decision-making, an update of knowledge transferable to develop palliative care programs that integrate the experiential, emotional, and contextual dimensions of palliative sedation, a better understanding of the communication skills needed to cope with this practice, and an awareness of health care teams and advocates. public health on this subject.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 36 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| QualiPas Observational | – | Other: a psycho-social investigationProspective qualitative study through a participant observation procedure with 8 care teams practicing within Palliative Care Units, Palliative Care Mobile Team or Territorial Palliative Care Team. |
| QualiPas clinical interview | – | Other: a psycho-social investigationQualitative study retrospective research interviews with the doctor and another carer involved in the care of the patient, and close relatives of patients who had sedated before their death. The interviews will be based on 50 cases of patients who have been sedated. |
| QualiPas Focus | – | Other: a psycho-social investigationQualitative study by group focus group interviews with clinical teams participating in the project. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- In the framework of the QualiPaS_OBS study, the observations will be made by a psychologist integrated into each care team during the observations observation period - no professional activity other than observations. The population studied in the QualiPaS_OBS phase corresponds to the members of the health care team practicing within the eight teams of the services participating in the study, as well as secondarily the patients and relatives of the patients concerned by the activity of the team in question. during the observation period.
Key inclusion criteria (4 listed)
- Men and women
- Anyone from the team during the observation period
- Having accepted the presence of the observer
- Aged over 18
Key exclusion criteria (2 listed)
- Members of the health care team not present during the observation period
- Member of the team refusing the presence of the observer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| a psycho-social investigationThe design of this project is based partly on the UNBIASED international study and is based on an in-depth case study in a prospective and retrospective dimension of deceased cancer patients for whom sedation has been established, and this, during a given period in different care settings: home, care center, hospital and palliative care unit. | Other | QualiPas Focus, QualiPas Observational, QualiPas clinical interview |
Primary outcome
Assessing the quality of life
Time frame: 36 months
Quality of Life Questionnaire
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2019.
- Derived from this study: PubMed 34223516Vieille M, Dany L, Coz PL, Avon S, Keraval C, Salas S, Bernard C. Perception, Beliefs, and Attitudes Regarding Sedation Practices among Palliative Care Nurses and Physicians: A Qualitative Study. Palliat Med Rep. 2021 May 24;2(1):160-167. doi: 10.1089/pmr.2021.0022. eCollection 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrcik SUDOUR contact
Emilie Garrido study director
Assistance Publique Hopitaux De Marseille
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of End Stage Cancer, run by Assistance Publique Hopitaux De Marseille at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lionel DANY, MD/PhD (+336.63.42.41.04, lionel.dany@univ-amu.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessing the quality of life (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04016038, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2019; AzTrials last refreshed its copy on 30 Oct 2026.